FDA UDI
Not in Commercial Distribution
🇺🇸 United States
ATTAIN CLARITY™
DI: 00643169181717
·
Model: 6225
·
MEDTRONIC, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- ATTAIN CLARITY™
- Primary DI
- 00643169181717
- Version / Model
- 6225
- Company Name
- MEDTRONIC, INC.
- Labeler DUNS
- 006261481
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-04-11
- Public Version
- 4
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 20c60478-ca94-4dae-bdee-e31104f50040
- Distribution End Date
- 2018-05-17
Device Description
Balloon Catheter 6225 Attain Clarity
Device Characteristics
- Single Use
- Yes
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- No
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- Yes
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| DQY | CATHETER, PERCUTANEOUS | Cardiovascular | 870.1250 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 17613 | Cardiac ventriculography catheter | A flexible tube with specific tip configurations designed to enter the left or right ventricle to perform diagnostic haemodynamic/angiographic procedures with contrast media. The distal tip may have an end hole and/or several side holes. The tube is introduced into a peripheral blood vessel and its distal tip is placed in the left or right ventricle according to the desired ventriculography. Left ventriculography is used to assess impairment of the left ventricle, the presence of ventricular aneurysms or septal defects, or to assess the mitral valve. Right ventriculography is used mostly to asses congenital heart disease. This is a single-use device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00643169181717 | GS1 |
Customer Contacts
- Phone
- +1(800)633-8766
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K121219 | 000 |
Device Sizes
| Type | Value | Unit | Text |
|---|---|---|---|
| Device Size Text, specify | Minimum guide catheter inner diameter 1.9 mm (5.7 Fr) | ||
| Device Size Text, specify | Nominal balloon diameter 13 mm | ||
| Device Size Text, specify | Catheter usable length 90 cm | ||
| Device Size Text, specify | Maximum guidewire diameter 0.018 in (0.46 mm) | ||
| Device Size Text, specify | Nominal inflation volume 2.5 ml | ||
| Device Size Text, specify | Maximum inflation volume 2.75 ml |
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- – 104 Degrees Fahrenheit
- Type
- Storage Environment Temperature
- Temperature Range
- – 40 Degrees Celsius